Relapsed/Refractory Multiple MyelomaNCT06888752
LCAR-M61SQ in Treatment of Relapsed/Refractory Multiple Myeloma
A study testing Cell injection in people with Relapsed/Refractory Multiple Myeloma, run by First Affiliated Hospital of Wenzhou Medical University.
Trial summary
A prospective, open-label dose-exploration and expansion study to evaluate the safety, tolerability, pharmacokinetics, and antitumor efficacy characteristics of LCAR-M61SQ in patients with relapsed/refractory multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed/Refractory Multiple Myeloma
- What is being tested?
- Cell injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 20 Mar 2025to 30 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects voluntarily participate in clinical research;
- Age ≥18 years old;
- Eastern Cooperative Oncology Group (ECOG) score 0-2;
- Examination evidence of initial diagnosis of MM according to IMWG diagnostic criteria;
- Measurable lesions were present;
- Subjects have received at least three previous lines of multiple myeloma therapy, each with at least one complete therapy cycle, unless the best response to the therapeutic regimen was documented as disease progression (PD confirmed according to IMWG criteria);
- Expected survival ≥3 months;
- Clinical laboratory values in the screening period meet criteria;
Who cannot join
- Received previous therapy targeting GPRC5D targets;
- Prior antineoplastic therapy and meet exclusion criteria (before apheresis);
- Subjects had Waldenstrom macroglobulinemia, POEMS syndrome, or primary AL amyloidosis at the time of screening.
- Subjects who were positive for any of HBsAg, HBV DNA, HCV-Ab, HCV RNA, and HIV-Ab;
- Life-threatening allergic reactions, hypersensitivity reactions, or intolerance to CAR-T cell formulations or their excipients, including DMSO, are known.
- Serious underlying diseases were present;
- Female subjects who were pregnant, breastfeeding, or planning to become pregnant while participating in this study or within 1 year of receiving study treatment.
- Also enrolled in other clinical studies.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Clinical Study to Evaluate the Safety, Tolerance and Efficacy of LCAR-M61SQ Cell in Patients with Relapsed/Refractory Multiple Myeloma.
A prospective, open-label dose-exploration and expansion study to evaluate the safety, tolerability, pharmacokinetics, and antitumor efficacy characteristics of LCAR-M61SQ in patients with relapsed/refractory multiple myeloma.
Read the detailed description
This study is a prospective, open-label clinical study to evaluate the safety, tolerability, pharmacokinetics, and antitumor efficacy characteristics of LCAR-M61SQ in patients with relapsed/refractory multiple myeloma. All subjects who meet the eligibility criteria will receive intravenous injection of LCAR-M61SQ cell injection. The study will include the following sequential phases: screening, apheresis, pre-treatment (lymphodepleting chemotherapy), treatment, and follow-up.
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Being tested
- Cell injection
- Keywords
- multiple myeloma, Relapsed/Refractory multiple myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cell injectionBiological
LCAR-M61SQ cells intravenous infusion; Prior to infusion of the LCAR-M61SQ cell, Subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine.
| Study group | Role | What they receive |
|---|---|---|
| LCAR-M61SQ | Experimental | Each subject will be given a single-dose LCAR-M61SQ cells infusion at each dose level Receives: Biological: Cell injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT) rate.
DLT is classified according to the NCI-CTCAE V5.0 toxicity evaluation criteria and ASTCT consensus classification within 30 days after dose infusion (D1-D30), which is considered by the investigator or collaborator to be reasonably related to LCAR-M61SQ cell therapy.
Measured: From LCAR-M61SQ cell infusion (Day 1) until the 30th day of follow-up period, assessed up to 30 days
Incidence, severity, and type of treatment-emergent adverse events (TEAEs)
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Measured: From the date of signing ICF to the date (2 years after LCAR-M61SQcell infusion
To determine the recommended dose for phase II clinical trials (RP2D)
RP2D established through accelerated titration design (ATD) and Bayesian Optimal Interval (BOIN) design.
Measured: through the last subject of DLT exploration completion, about 2years.
Maximum concentration (Cmax)
The maximum observed concentration of CAR positive T cells or transgene CAR copy number in peripheral blood.
Measured: From the 7th days before first dose of pretreatment with chemotherapy until the date of first documented progression or study completion，assessed about 2 years
Time to Cmax
The time it takes to reach the maximum concentration of CAR positive T cells or transgene CAR copy number in peripheral blood.
Measured: From the 7th days before first dose of pretreatment with chemotherapy until the date of first documented progression or study completion，assessed about 2 years
Time to the last observed concentration
The time it takes to reach the last observed concentration of CAR positive T cells or transgene CAR copy number in peripheral blood.
Measured: From the 7th days before first dose of pretreatment with chemotherapy until the date of first documented progression or study completion，assessed about 2 years
Area Under the Curve (AUC) of the concentration
The exposure of CAR positive T cells or transgene CAR copy number in peripheral blood experienced by the subject in a certain time interval.
Measured: From the 7th days before first dose of pretreatment with chemotherapy until the date of first documented progression or study completion，assessed about 2 years
Secondary outcomes (10)
Objective Response Rate (ORR)
According to International Myeloma Working Group (IMWG) efficacy criteria. ORR is defined as the proportion of patients with PR or better response after infusion of LCAR-M61SQ cells.
Measured: From the 7th days before first dose of pretreatment with chemotherapy until the date of first documented progression or study completion，assessed about 2 years
Very Good Partial Response Rate（VGPR）
Proportion of subjects achieving VGPR according to IMWG criteria.
Measured: From the 7th days before first dose of pretreatment with chemotherapy until the date of first documented progression or study completion，assessed about 2 years
Complete response（CR）
Proportion of subjects achieving CR according to IMWG criteria.
Measured: From the 7th days before first dose of pretreatment with chemotherapy until the date of first documented progression or study completion，assessed about 2 years
Stringent complete response（sCR）
Proportion of subjects achieving sCR according to IMWG criteria.
Measured: : From the 7th days before first dose of pretreatment with chemotherapy until the date of first documented progression or study completion，assessed about 2 years
Minimal residual disease (MRD) negative rate
Proportion of subjects achieving minimal residual disease (MRD) negative rate according to IMWG criteria.
Measured: From the 7th days before first dose of pretreatment with chemotherapy until the date of first documented progression，assessed about 2 years
Time-to-response（TTR）
According to International Myeloma Working Group (IMWG) efficacy criteria. TTR is defined as the interval from the date of the first infusion of the LCAR-M61SQ cells to the date of the first efficacy assessment for which the subject met all criteria for PR or better. Analyses were performed only in responders.
Measured: From the 7th days before first dose of pretreatment with chemotherapy until the date of first documented progression or study completion，assessed about 2 years
Duration of response（DOR）
According to International Myeloma Working Group (IMWG) efficacy criteria. DOR is defined as the time from the first documented response (PR or better response) to the first documented evidence of disease progression (as defined according to IMWG criteria) or death from any cause .
Measured: From the 7th days before first dose of pretreatment with chemotherapy until the date of first documented progression or study completion，assessed about 2 years
Progression-free survival（PFS）
According to International Myeloma Working Group (IMWG) efficacy criteria. PFS is defined as the interval from the date of the first infusion of the LCAR-M61SQ cells to the first documentation of disease progression (according to IMWG criteria) or death from any cause, whichever occurred first.
Measured: From the 7th days before first dose of pretreatment with chemotherapy until the date of first documented progression or study completion，assessed about 2 years
Overall survival（OS
According to International Myeloma Working Group (IMWG) efficacy criteria.
Overall survival (OS) is defined as the interval from the date of the first infusion of LCAR-M61SQ cells to death.
Measured: From the 7th days before first dose of pretreatment with chemotherapy until the date of first documented progression or study completion，assessed about 2 years
Occurrence rate of antidrug antibody
Occurrence rate of LCAR-M61SQ cells preparation ADA.
Measured: From LCAR-M61SQ cells infusion until the date of first documented progression or study completion，assessed about 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start20 Mar 2025 (estimated)
- Primary completion30 Jun 2030 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment ，LCAR-61SQ cells intravenous infusion Pretreatment of cyclophosphamide and fludarabine.
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Boren Hospital, First People's Hospital of Hangzhou
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06888752
- Sponsor's protocol ID
- LB2403-0001
- Status last verified
- Mar 2025
- First submitted
- 17 Mar 2025
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Safety, Tolerance and Efficacy of LCAR-M61SQ Cell in Patients with Relapsed/Refractory Multiple Myeloma.
- ClinicalTrials.gov ID
- NCT06888752
- Acronym / sponsor ID
- LB2403-0001
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Keywords
- multiple myeloma, Relapsed/Refractory multiple myeloma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Collaborators
- Beijing Boren Hospital, First People's Hospital of Hangzhou
- Study start
- 20 Mar 2025 (estimated)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 21 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, open-label dose-exploration and expansion study to evaluate the safety, tolerability, pharmacokinetics, and antitumor efficacy characteristics of LCAR-M61SQ in patients with relapsed/refractory multiple myeloma.
Detailed description
This study is a prospective, open-label clinical study to evaluate the safety, tolerability, pharmacokinetics, and antitumor efficacy characteristics of LCAR-M61SQ in patients with relapsed/refractory multiple myeloma. All subjects who meet the eligibility criteria will receive intravenous injection of LCAR-M61SQ cell injection. The study will include the following sequential phases: screening, apheresis, pre-treatment (lymphodepleting chemotherapy), treatment, and follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment ，LCAR-61SQ cells intravenous infusion Pretreatment of cyclophosphamide and fludarabine.
| Arm | Type | Receives |
|---|---|---|
| LCAR-M61SQ | Experimental | Biological: Cell injectionEach subject will be given a single-dose LCAR-M61SQ cells infusion at each dose level |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects voluntarily participate in clinical research;
- Age ≥18 years old;
- Eastern Cooperative Oncology Group (ECOG) score 0-2;
- Examination evidence of initial diagnosis of MM according to IMWG diagnostic criteria;
- Measurable lesions were present;
Key exclusion criteria (8 listed)
- Received previous therapy targeting GPRC5D targets;
- Prior antineoplastic therapy and meet exclusion criteria (before apheresis);
- Subjects had Waldenstrom macroglobulinemia, POEMS syndrome, or primary AL amyloidosis at the time of screening.
- Subjects who were positive for any of HBsAg, HBV DNA, HCV-Ab, HCV RNA, and HIV-Ab;
- Life-threatening allergic reactions, hypersensitivity reactions, or intolerance to CAR-T cell formulations or their excipients, including DMSO, are known.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cell injectionLCAR-M61SQ cells intravenous infusion; Prior to infusion of the LCAR-M61SQ cell, Subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine. | Biological | LCAR-M61SQ |
Primary outcome
Dose-limiting toxicity (DLT) rate.
Time frame: From LCAR-M61SQ cell infusion (Day 1) until the 30th day of follow-up period, assessed up to 30 days
DLT is classified according to the NCI-CTCAE V5.0 toxicity evaluation criteria and ASTCT consensus classification within 30 days after dose infusion (D1-D30), which is considered by the investigator or collaborator to be reasonably related to LCAR-M61SQ cell therapy.
Incidence, severity, and type of treatment-emergent adverse events (TEAEs)
Time frame: From the date of signing ICF to the date (2 years after LCAR-M61SQcell infusion
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
To determine the recommended dose for phase II clinical trials (RP2D)
Time frame: through the last subject of DLT exploration completion, about 2years.
RP2D established through accelerated titration design (ATD) and Bayesian Optimal Interval (BOIN) design.
Maximum concentration (Cmax)
Time frame: From the 7th days before first dose of pretreatment with chemotherapy until the date of first documented progression or study completion，assessed about 2 years
The maximum observed concentration of CAR positive T cells or transgene CAR copy number in peripheral blood.
Time to Cmax
Time frame: From the 7th days before first dose of pretreatment with chemotherapy until the date of first documented progression or study completion，assessed about 2 years
The time it takes to reach the maximum concentration of CAR positive T cells or transgene CAR copy number in peripheral blood.
Time to the last observed concentration
Time frame: From the 7th days before first dose of pretreatment with chemotherapy until the date of first documented progression or study completion，assessed about 2 years
The time it takes to reach the last observed concentration of CAR positive T cells or transgene CAR copy number in peripheral blood.
Area Under the Curve (AUC) of the concentration
Time frame: From the 7th days before first dose of pretreatment with chemotherapy until the date of first documented progression or study completion，assessed about 2 years
The exposure of CAR positive T cells or transgene CAR copy number in peripheral blood experienced by the subject in a certain time interval.
10 secondary outcomes
Objective Response Rate (ORR)
Time frame: From the 7th days before first dose of pretreatment with chemotherapy until the date of first documented progression or study completion，assessed about 2 years
Very Good Partial Response Rate（VGPR）
Time frame: From the 7th days before first dose of pretreatment with chemotherapy until the date of first documented progression or study completion，assessed about 2 years
Complete response（CR）
Time frame: From the 7th days before first dose of pretreatment with chemotherapy until the date of first documented progression or study completion，assessed about 2 years
Stringent complete response（sCR）
Time frame: : From the 7th days before first dose of pretreatment with chemotherapy until the date of first documented progression or study completion，assessed about 2 years
Minimal residual disease (MRD) negative rate
Time frame: From the 7th days before first dose of pretreatment with chemotherapy until the date of first documented progression，assessed about 2 years
Time-to-response（TTR）
Time frame: From the 7th days before first dose of pretreatment with chemotherapy until the date of first documented progression or study completion，assessed about 2 years
Duration of response（DOR）
Time frame: From the 7th days before first dose of pretreatment with chemotherapy until the date of first documented progression or study completion，assessed about 2 years
Progression-free survival（PFS）
Time frame: From the 7th days before first dose of pretreatment with chemotherapy until the date of first documented progression or study completion，assessed about 2 years
Overall survival（OS
Time frame: From the 7th days before first dose of pretreatment with chemotherapy until the date of first documented progression or study completion，assessed about 2 years
Occurrence rate of antidrug antibody
Time frame: From LCAR-M61SQ cells infusion until the date of first documented progression or study completion，assessed about 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Cell injection in people with Relapsed/Refractory Multiple Myeloma, run by First Affiliated Hospital of Wenzhou Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Songfu Jiang, MD (15305770033, jiangsongfu@189.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (DLT) rate. (time frame: From LCAR-M61SQ cell infusion (Day 1) until the 30th day of follow-up period, assessed up to 30 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.